TOPIC : Progress novel assets (one FTIH start) for non-tubercular mycobacteria (NTM) that may act synergistically with bedaquiline and cytochrome bc drugs
|Publication date:||18 July 2018|
|Types of action:||IMI2-RIA Research and Innovation action|
|DeadlineModel: Opening date:||single-stage 18 July 2018||Deadline:||24 October 2018 17:00:00|
|Time Zone : (Brussels time)|
Topic DescriptionSpecific Challenge:
The Portfolio Building Network (PBN), Pillar C of the IMI2 JU AMR Accelerator programme, will address the limited pipeline of treatments and preventions for AMR infections by enabling vibrant and nimble collaborations between EFPIA companies and small and medium-sized enterprises (SMEs) and/or academics that will advance the R&D pipeline of new and innovative agents to address AMR.Scope:
The project goal is to develop and advance a portfolio of anti-NTM drugs that may be used in combination with bedaquiline and cytochrome bc inhibitors to shorten treatment regimens and improve safety and efficacy. The EFPIA partner’s internal assets as well as external compounds will be profiled alone and in combination. The scope of this topic will be to progress novel lead compounds by performing medicinal chemistry optimisation, in vitro and in vivo characterisation, as well as PK, toxicology studies, formulation and CMC (chemistry, manufacturing and controls) studies. The scope also includes implementation of phase 1 studies towards the development of novel NTM candidates.Expected Impact:
The expected impact of actions selected under this Call will be to: (1) contribute to the development of a vibrant AMR research environment in the EU and strengthen the competitiveness and industrial leadership of Europe; (2) contribute to the EU’s ambition of being a ‘best practice region’ for addressing AMR; (3) enhance the overall pipeline of medicines for patients with AMR infections and advance new and innovative agents.
Topic conditions and documents
Please read carefully all provisions stated below before the preparation of your application.
The IMI2 JU 16th Call for proposals topics text as well as the Call Conditions are available here.
The budget breakdown for this Call is given at the end of the Call topics text, in the Call Conditions section, as well as the following information :
2. Eligibility and admissibility conditions: described in the IMI2 Manual for evaluation, submission and grant award. See also the Commission Delegated Regulation related to IMI JU.
Proposal page limits and layout: Please refer to Part B of the proposal template in the submission tool below.
Submission and evaluation process, including evaluation criteria and procedure, scoring and threshold are described in the IMI2 Manual for submission, evaluation and grant award. See also the proposal templates for your specific action in section 5, below.
4. Indicative time for evaluation and grant agreement:
Notification of outcomes of the evaluation: maximum 5 months from deadline for submitting proposals.
Signature of grant agreements: maximum 3 months from the date of informing successful applicants.
5. Proposal templates, evaluation forms and model grant agreements (MGA):
IMI2 Research and Innovation Action (IMI2-RIA) and Innovation Action (IMI2-IA):
Proposal templates are available after entering the submission tool
Standard evaluation form
Clinical trial template – the Clinical Trial template is compulsory at stage 2 only !
6. Open access must be granted to all scientific publications resulting from Horizon 2020 actions.
Where relevant, proposals should also provide information on how the participants will manage the research data generated and/or collected during the project, such as details on what types of data the project will generate, whether and how this data will be exploited or made accessible for verification and re-use, and how it will be curated and preserved.
Open access to research data
The Open Research Data Pilot has been extended to cover all Horizon 2020 topics for which the submission is opened on 26 July 2016 or later. Projects funded under this topic will therefore by default provide open access to the research data they generate, except if they decide to opt-out under the conditions described in Annex L of the H2020 main Work Programme. Projects can opt-out at any stage, that is both before and after the grant signature.
Note that the evaluation phase proposals will not be evaluated more favourably because they plan to open or share their data, and will not be penalised for opting out.
Open research data sharing applies to the data needed to validate the results presented in scientific publications. Additionally, projects can choose to make other data available open access and need to describe their approach in a Data Management Plan.
Projects need to create a Data Management Plan (DMP), except if they opt-out of making their research data open access. A first version of the DMP must be provided as an early deliverable within six months of the project and should be updated during the project as appropriate. The Commission already provides guidance documents, including a template for DMPs. See the Online Manual.
Eligibility of costs: costs related to data management and data sharing are eligible for reimbursement during the project duration.
The legal requirements for projects participating in this pilot are in the article 29.3 of the Model Grant Agreement.
Members of consortium are required to conclude a consortium agreement prior to the signature of the grant agreement.
7. Additional documents:
No submission system is open for this topic.
H2020 Online Manual is your guide on the procedures from proposal submission to managing your grant.
Participant Portal FAQ – Submission of proposals.
National Contact Points (NCP) - contact your NCP for further assistance in your national language(s).
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CEN and CENELEC, the European Standards Organisations, advise you how to tackle standardisation in your project proposal. Contact CEN-CENELEC Research Helpdesk at email@example.com
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IMI2 States Representative Group (SRG) – contact you SRG member for assistance.
IMI2 JU Applicants Helpdesk – contact the IMI2 Programme Office.